The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations:

· Neurosurgery
· Gastrointestinal and Affiliated Organ Surgery
· Urological surgery
· Plastic and Reconstructive surgery
· General Surgery
· Orthopedic Surgery
· Gynecological Surgery
· Thoracic Surgery
· Wound Care
· Laparoscopic Surgery
· Thoracoscopic Surgery

Device Description

The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissue, and can also be used for precise cutting, crushing and shaping of bone tissue. The product can be applied to a number of departments by using the suitable parameters and accessories, including:

. Department of Neurosurgery, general surgery and other departments for soft tissue cutting, breakage and aspiration.
. Department of Orthopedic surgery, Plastic and Reconstructive surgery, Department of Neurosurgery (only for bone) for bone cutting.
. As well as the Department of Dermatology, Department of Trauma Orthopedics and other departments used for debridement.
The XD880B Ultrasonic Surgical Aspirator System consists of a console, foot switch, and accessories. The accessories include handpiece, tips, wrench, liquid-flow tube, sterilization tray, suction bag, suction canister and mobile cart. The handpiece, tips, liquid-flow tube are assembled into ultrasonic tool part to complete the cutting and fragment of bone tissue and soft tissues.

AI/ML Overview

This document describes the FDA 510(k) clearance for the Ultrasonic Surgical Aspirator System (XD880B), focusing on its substantial equivalence to predicate devices rather than a direct clinical performance study with acceptance criteria.

Therefore, the specific information requested, such as a table of acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone algorithm performance, is not present or applicable in the provided document.

The document details the device's technical specifications and non-clinical performance data to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information in the context of your request:

1. A table of acceptance criteria and the reported device performance:

Not applicable in the context of this document. This document focuses on demonstrating substantial equivalence based on technical characteristics and non-clinical testing, not on achieving specific clinical performance metrics against predefined acceptance criteria from a clinical trial.
The "performance" described is in terms of passing various non-clinical standard tests (e.g., electrical safety, EMC, software verification, sterilization validation, shelf-life, lifetime validation, acoustic performance, efficiency and temperature characteristics).

2. Sample sizes used for the test set and the data provenance:

Not applicable. This submission relies on non-clinical testing and comparison to predicate devices, not on a clinical test set in the way a diagnostic AI would.
The document implies that various units of the device and its components were tested to meet the specified non-clinical standards, but explicit "sample sizes" for a clinical test set are not mentioned as no clinical performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical ground truth establishment involving human experts is described. The "truth" for this submission is based on engineering standards and technical specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. A MRMC study was not conducted as this is an ultrasonic surgical aspirator system, not a diagnostic AI system designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is a surgical tool, not a standalone diagnostic algorithm. Its function inherently involves human operation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Technical Specifications and Standard Compliance: The "ground truth" for this submission is adherence to engineering specifications and compliance with international and national standards for medical devices (e.g., IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMC, IEC 62304 for software, ISO 17665-1 and ISO 11135 for sterilization). The device's performance is measured against these established technical benchmarks.

8. The sample size for the training set:

Not applicable. This is a hardware medical device, not an AI/ML model that requires a "training set" in the computational sense.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary of Device Acceptance (from the document's perspective):

The acceptance mechanism for this device's FDA clearance is "Substantial Equivalence" to legally marketed predicate devices. This is achieved by demonstrating that the new device:

Has the same intended use.
Has the same or similar indications for use.
Has the same or similar technological characteristics.
Does not raise new or different questions of safety or effectiveness.

Studies/Data that Proved Device Meets "Acceptance Criteria" (i.e., Substantial Equivalence):

The document states that the following non-clinical tests were conducted and passed to support substantial equivalence:

Electrical safety testing per IEC 60601-1
EMC testing per IEC 60601-1-2
Software verification and validation per IEC 62304 / FDA Guidance
Moist heat sterilization validation per ISO 17665-1
EO sterilization validation per ISO 11135 (demonstrates SAL of 10^-6)
Shelf-life Testing
Lifetime validation test for handpieces
Acoustic Performance Test per IEC 61847
Efficiency and Temperature Characteristics Test

These tests confirm that the device's design inputs and performance specifications are met, allowing the FDA to determine that it is as safe and effective as the predicate devices, thereby meeting the "acceptance criteria" for 510(k) clearance by way of substantial equivalence.

Summary

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May 21, 2021

SMTP Technology Co., Ltd % Randy Jiang Sr. consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K202299

Trade/Device Name: Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL Dated: April 13, 2021 Received: April 19, 2021

Dear Randy Jiang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdth/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements,

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including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and. if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations. please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202299

Device Name

Ultrasonic Surgical Aspirator System

Indications for Use (Describe)

· Neurosurgery
· Gastrointestinal and Affiliated Organ Surgery
· Urological surgery
· Plastic and Reconstructive surgery
· General Surgery
· Orthopedic Surgery
· Gynecological Surgery
· Thoracic Surgery
· Wound Care
· Laparoscopic Surgery
· Thoracoscopic Surgery

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 201 Subpart D)	Over-The-Counter Use (21 CFR 201 Subpart C)
----------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------

| X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Ultrasonic Surgical Aspirator System

1. Submission Sponsor

SMTP Technology Co., Ltd. 1F&4F, Building A, Emerging Incubation Center, Zhangjiagang Free Trade Zone, Jiangsu Province, China. Contact: Songtao Zhan Title: CTO Phone number: +86-10-88572898

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Randy Jiang Title: Senior Consultant

3. Date Prepared

May, 19th, 2021

4. Device Identification

Trade/Proprietary Name:	Ultrasonic Surgical Aspirator System
Common/Usual Name:	Ultrasonic Surgical Aspirator
Classification Name:	instrument, ultrasonic surgical
Regulation Number:	N/A, Pre-Amendment
Product Code:	LFL
Class:	Unclassified
Classification Panel:	General & Plastic Surgery

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	K#	Name	Manufacturer
Primary PredicateDevice	K070313	Alliger Ultrasonic Surgical SystemModel AUSS-7	Misonix Inc.
Secondary PredicateDevice	K062471	FS 1000 RF Ultrasonic SurgicalAspirator System and Accessories	Misonix Inc.
Reference Device	K172464	XD880A Ultrasonic OsteotomySurgical System	SMTP Technology Co., Ltd

5. Legally Marketed Predicate Device(s)

6. Indication for Use Statement

The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations:

Neurosurgery
Gastrointestinal and Affiliated Organ Surgery
Urological Surgery
. Plastic and Reconstructive Surgery
General Surgery
Orthopedic Surgery
. Gynecological Surgery
Thoracic Surgery
Wound Care
. Laparoscopic Surgery
Thoracoscopic Surgery

7. Device Description

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. Department of Neurosurgery, general surgery and other departments for soft tissue cutting, breakage and aspiration.
. Department of Orthopedic surgery, Plastic and Reconstructive surgery, Department of Neurosurgery (only for bone) for bone cutting.
. As well as the Department of Dermatology, Department of Trauma Orthopedics and other departments used for debridement.

The XD880B Ultrasonic Surgical Aspirator System consists of a console, foot switch, and accessories. The accessories include handpiece, tips, wrench, liquid-flow tube, sterilization tray, suction bag, suction canister and mobile cart. The handpiece, tips, liquid-flow tube are assembled into ultrasonic tool part to complete the cutting and fragment of bone tissue and soft tissues.

8. Substantial Equivalence Discussion

The following Table 1 compares the Ultrasonic Surgical Aspirator System to the predicate devices with respect to intended use, power supply, product classification, irrigation system, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate devices.

Attribute	Subject device	Primary Predicate Device(K070313)	Secondary PredicateDevice (K062471)
Manufacturer	SMTP Technology Co.,Ltd.	Misonix Inc.	Misonix Inc.
Classification	Unclassified	Unclassified	Unclassified
Common/UsualName	Ultrasonic SurgicalAspiratorUltrasonic SurgicalSystem	Ultrasonic SurgicalAspiratorUltrasonic Surgical System	Ultrasonic SurgicalAspiratorUltrasonic SurgicalSystem
Regulation Panel	General & PlasticSurgery	General & Plastic Surgery	General & Plastic Surgery
Product Code	LFL	LFL	LFL
Indications forUse	The XD880B UltrasonicSurgical AspiratorSystem is an ultrasonicsurgical systemconsisting of	The Misonix Inc. AUSS-7Ultrasonic Surgical Systemis indicated for use in thefragmentation andaspiration of both soft and	The Misonix Inc. FS 1000RE Ultrasonic AspiratorSystem is indicated foruse in the fragmentation,emulsification and
	handpieces andassociated tips. Theproduct is intended forthe fragmentation,emulsification andaspiration of both softand hard (i.e. bone andbone approximations)tissue, the intendeduse is as follows withdifferentconfigurations:Neurosurgery Gastrointestinaland AffiliatedOrgan Surgery Urological Surgery Plastic andReconstructiveSurgery General Surgery OrthopedicSurgery GynecologicalSurgery Thoracic Surgery Wound Care LaparoscopicSurgery ThoracoscopicSurgery	hard (e.g.: bone) tissue inthe following surgicalspecialties:Neurosurgery Gastrointestinal andAffiliated OrganSurgery Urological Surgery Plastic andReconstructiveSurgery General Surgery Orthopedic Surgery Gynecology Thoracic Surgery Wound Care	aspiration of both softand hard (i.e. bone)tissue in the followingsurgical specialties:Neurosurgery Gastrointestinal andAffiliated OrganSurgery Urological Surgery Plastic andReconstructiveSurgery General Surgery Orthopedic Surgery GynecologicalSurgery Thoracic Surgery LaparoscopicSurgery ThoracoscopicSurgery The system may also becombined withelectrosurgery usingoptional RF Surgeryinterface components.
Vibration System	Continuous WaveFrequency:39kHz & 52kHz	Continuous WaveFrequency:22.0-24.5 kHz	Continuous WaveFrequency: 23+/-1 kHz or22-24 kHz
Electrical PowerSupply	100-240 VAC 50/60 Hz.	100-130 VAC 6.5 Amps,50/60 Hz200/250 VAC 2.25 Amps,50/60 Hz	115 VAC and 230 VAC50/60Hz
Power InputCurrent	3.6A max	6.5A at 100-130 VAC,3.25A at 200/250 VAC	4A max
Footswitch	Foot switch connectedto the device controlunit by means of acord.	Wired (connected to rearpanel of console), Singlepedal footswitch toactivate delivery ofultrasound and irrigation	Wired- On/Off Pedal foramplitude, irrigation andaspiration - Flush Button- COAG with CUT lockoutfeature- COAG simultaneouswith ultrasound- COAG only
Console	The functionalparameters aredisplayed andcontrolled through aconsole with touchscreen.	Console with membranecontrol panel and graphicaluser interface	Console with membranecontrol panel and LEDindicators.
Device containsSoftware	Yes	Yes	Yes
Irrigation System	Peristaltic pump.	Peristaltic pump	Peristaltic pump
Irrigation fluid	Adjustable between:5 to 120 ml/min.	Adjustable:0 - 100 ml/min	Up to 10cc/min
AspirationVacuum	600mmHg (80kPa)maximum	Max: 28" Hg Max	Min: less than 0.5" HgMax: 25" Hg
Dimensions	18.0cm H × 31.0cm W ×53.5cm D	18.0cm H x 41.0cm W x68.5cm D	102cm H x 63.5cm W x48cm D
Weight	9.3kg	11.6 kg	54.5 kg

Table 1 – Comparison of Characteristics

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9. Non-Clinical Performance Data

To demonstrate safety and effectiveness of XD880B Ultrasonic Surgical Aspirator System and to show substantial equivalence to the predicate devices, SMTP Technology Co., Ltd. completed the following nonclinical tests. Results confirm that the design inputs and performance specifications for the device are met. The XD880B Ultrasonic Surgical Aspirator System passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate devices:

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Electrical safety testing per IEC 60601-1 - Passed
. EMC testing per IEC 60601-1-2 - Passed
. Software verification and validation per IEC 62304/FDA Guidance - Passed
. Moist heat sterilization validation per ISO 17665-1- Passed
EO sterilization validation per ISO 11135 - Passed, demonstrates SAL of 106
Shelf-life Testing - Passed
Lifetime validation test for handpieces - Passed
. Acoustic Performance Test per IEC61847 - Passed
. Efficiency and Temperature Characteristics Test - Passed

10. Clinical Performance Data

Not applicable.

11. Statement of Substantial Equivalence

The XD880B Ultrasonic Surgical Aspirator System has the same intended use as the predicate devices, and the same or similar indications and technological characteristics. The differences do not raise new or different questions of safety and effectiveness. Electrical safety and performance testing have demonstrated the XD880B Ultrasonic Surgical Aspirator System is as safe and effective as the predicate devices. Therefore, the XD880B Ultrasonic Surgical Aspirator System is substantially equivalent to the predicate devices.

Regulation Number and Section

N/A